Kornimate/medical-research-clean huggingface dataset:
investigating the microbiome and volatile organic compound profile of children with neuroblastoma

Conditions: Microbial Colonization; Neuroblastoma; Children, Only

Summary: background: malignant tumors may lead to a catabolic state with loss of muscle and adipose tissue. the full picture of catabolism is termed cachexia and is associated with significant morbidity and mortality of cancer patients. although the full picture is rarely observed up to 50% of children with cancer suffer from significant malnourishment. additionally to tumor-induced catabolism, side-effects of chemotherapy may be problematic for the patients. in this regard up to 60% of children suffer from gastrointestinal mucositis presenting with nausea, vomiting, diarrhea or constipation and abdominal pain. in the worst case, mucositis may lead to bacterial translocation with life-threatening inflammatory response. clinically this may require a reduction of the dosage or the number of chemotherapy cycles resulting in reduced effectivity. up to now the therapy of mucositis is only symptomatic. recent research of the applicant has shown a significant reduction of lactobacilli in mice with neuroblastoma (a malignant childhood tumor). the dysbiosis was associated with catabolism, increased gut permeability and inflammation. astonishingly, chemotherapy alone also leads to a significant reduction of lactobacilli compared to sham mice, which may be linked to the development of mucositis clinically. overall, the intestinal microbiome seems to play an essential role in the development of tumor-associated catabolism and chemotherapy-induced mucositis. aim: the aim of this project is to determine if the changes in the intestinal microbiome observed in mice can also be seen in children with neuroblastoma. methods: one part of the study will include 10 children with neuroblastoma (inclusion after verification of the diagnosis) and 10 healthy controls. the fecal microbiome will be determined by 16s-ribosomal deoxyribonucleic acid (rdna) pyrosequencing. volatile organic compounds in the breath will be sampled and measured by gas chromatography/mass spectroscopy. a basic science human work package will address the question if there are differences. in the second part serial investigations in children with neuroblastoma will assess whether or not these patients show alterations of the intestinal microbiome under chemotherapy.


Eligibility criteria:
inclusion criteria: * age 2-8 years * neuroblastoma group: verified neuroblastoma * control group: absence of pulmonary or gastro-intestinal disease * written parental informed consent obtained exclusion criteria: * active gastro-intestinal or pulmonary disease * antibiotic or probiotic treatment within 3 weeks before sampling * negative parental informed consent

Keywords: microbiome volatile organic compounds neuroblastoma
the impact of "natural" cesarean delivery on peripartum maternal blood loss.

Conditions: Postpartum Hemorrhage

Summary: throughout the history, the neonate was dependent on maternal touch and care for survival. in modern obstetrics, with hospital care the neonates are seldom separated from their mothers after delivery. early skin to skin (ests) contact after delivery was found to increase milk production, lactation and improve maternal and neonatal outcome. oxytocin is the primary hormone responsible for uterine contraction and prevention of postpartum hemorrhage (pph). ests contact increases oxytocin secretion. the rate of cesarean deliveries (cds) increased dramatically over the past decades. cd was found to decrease postpartum milk production, postpones early lactation and decreases exclusive breastfeeding. during the typical cd, the neonate is usually presented for a short while to the mother and breastfeeding is usually delayed at least a number of hours until after the surgery and the recovery period. natural cd, enable ests contact during the surgery and give the mother the opportunity to start breastfeeding immediately after delivery of the neonate in the surgery suit. oxytocin secretion increases with ests and during breastfeeding. the aim of this study is to examine blood loss that occurs after natural cd compared to standard cd without an ests contact.


Eligibility criteria:
inclusion criteria: * estimated to be appropriate for gestational age fetus. * sonographic dating before 20 weeks of gestation. exclusion criteria: * non-scheduled cd. * major fetal malformations. * multiple gestations. * non-controlled diabetes. * severe pre-eclampsia. * general anesthesia. * hiv carrier * neonatal need for early resuscitation.
baclocur® post-authorisation safety study in real-life settings in france

Conditions: Alcohol Use Disorder

Summary: the overall goal of the study is to further characterize the risks and the safety profile of baclocur® in real life settings, over a 12-month follow-up period.

this is a prospective, multicenter, non-comparative non-interventional post-authorisation safety study (pass) conducted in france. there will be no experimental intervention utilized. enrolled patients will receive treatment and evaluations for their disease as determined by their physicians in accordance with local standard of care. visits will be scheduled by their physician according to patient-specific needs and national clinical practice. for purposes of this study, physicians will be requested to record information on enrolled patients at the time of study enrolment (baseline), and then to conduct follow-up patient visits based on their usual practice for a period of 12 months following baclocur® initiation. at study end, further investigations on patients confirmed as lost to follow-up (lfu) will be performed through the use of the french medico-administrative database called the système national des données de santé (snds). the goal will be to determine their vital status and collect relevant treatment and safety data over the studied period to further assess the safety of baclocur®. a probabilistic approach using relevant matching variables (e.g. gender, year of birth, date of baclocur prescription, department of care) will be used to retrieve these snds data of interest. the patient study enrolment period is expected to be approximately of 3 years. accounting for the 12 months follow-up period per patient, the full study field duration is expected to be approximately of 4 years. one additional year will be needed before the snds matching is performed, taken into account the delay required for the snds to be updated. with the final analysis and final clinical study report, this will lead to a total study duration of approximately 6 years.

Eligibility criteria:
inclusion criteria: 1. patient aged 18 or more; 2. initiating a treatment with baclocur®; 3. informed and having agreed to participate in the study; 4. covered by healthcare insurance. exclusion criteria: 1. current participation in a clinical trial; 2. previous treatment with baclofen/baclocur®; 3. patient deprived of liberty by a judicial or administrative decision, or who is under a measure of legal protection (e.g. guardianship or curatorship).
safety and immunogenicity of q fever vaccine

Conditions: Q Fever

Summary: the purpose of this study is to evaluate the safety of q fever vaccine, phase i, inactivated, dried, ndbr 105 and collect data on incidence of occupational q fever infection in vaccinated personnel.


Eligibility criteria:
inclusion criteria: * at least 18 years old. * females of childbearing potential must agree to have a urine pregnancy test on the same day before receipt of skin test and vaccine. (exception: documented hysterectomy or ≥ 3 years of menopause.) the results must be negative. females must agree to not become pregnant for 3 months after receipt of the skin test or vaccination. * considered at risk for exposure to c burnetii and who have submitted a request for investigational new drug (ind) vaccines for the q fever vaccine. * sign and date the approved informed consent document and health insurance portability and accountability act (hipaa) authorization. * have on their charts: * up-to-date medical history (including concomitant medications) * physical examination and laboratory tests within 1 year * previous chest x-ray and electrocardiogram * be medically cleared for participation by an investigator. examinations or tests may be repeated at the discretion of the enrolling physician. * willing to return for all follow-up visits. * agree to report any adverse events (aes) that may or may not be associated with administration of the test article for at least 28 days after vaccination and agree to report all serious adverse events (for example, resulting in hospitalization) for the duration of the subject's participation in the study (6 months). * agree to defer blood, bone marrow, and organ donation for 1 year after receipt of skin test antigen and/or vaccine. exclusion criteria: * prior history of q fever disease or vaccination. * clinically significant abnormal lab results (including evidence of hepatitis c, hepatitis b carrier state) or elevated liver function tests (two times the normal range or at the discretion of the principal investigator). * personal history of an immunodeficiency or current treatment with an oral or intravenous immunosuppressive medication. * confirmed hiv infection. * heart valve disease: prosthetic heart valve or clinically significant heart murmur. (if a murmur is detected on examination, an echocardiogram may be obtained or subject may be referred to a cardiologist to determine clinical significance.) * aneurysm/vascular graft. * joint prosthesis. * history of chronic fatigue syndrome (or positive by chronic fatigue syndrome (cfs) questionnaire criteria). * positive pregnancy test or breast-feeding female. * any known allergies to components of the vaccine: * formalin * eggs or chicken products * administration of another vaccine or investigational product within 28 days of skin test and subsequent q fever vaccination. * any unresolved ae resulting from a previous immunization. * transplant recipients, subjects with cancer, and those with chronic kidney disease. * a medical condition that, in the judgment of the principal investigator, would impact subject safety.

Keywords: q fever coxiella burnetii
safety and efficacy of iron sucrose in children

Conditions: Anemia; Chronic Kidney Disease

Summary: comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (ckd) patients

randomized, controlled, open label trial of pediatric ckd patients on stable erythropoietin (epo) therapy. patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)

Eligibility criteria:
inclusion criteria: * patients between 2 to 21 years of age * patients on stable hemodialysis (hd) or peritoneal dialysis (pd) regimen for 3 months for ≥ 3 months * non-dialysis dependent (ndd) patients with glomerular filtration rate (gfr) \<60 * hemoglobin (hgb) ≥ 11g/dl to ≤ 13.5g/dl * ferritin ≤ 800 ng/ml * transferrin saturation (tsat) ≥ 20% to ≤ 50% * received stable erythropoietin (epo) regimen for ≥ 8 weeks prior to the qualifying screening visit exclusion criteria: * known hypersensitivity to iron sucrose * severe diseased of the liver, cardiovascular system, or hemopoietic system * serious infection requiring hospitalization * significant blood loss within the last 3 months * bleeding disorders * pregnancy / lactation * actively being treated for asthma * hemoglobinopathy * receiving a myelosuppressive drug

Keywords: iron anemia ckd
evaluation of the analgesic effect of midazolam and ketamine as an additive to intrathecal bupivacaine in patients undergoing cesarean section

Conditions: Post Operative Pain

Summary: objective :to compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section . methods:following ethics committee approval and informed patients consent, ninety patients 18-45 yr old asa physical status i or ii, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. the patients were randomly allocated to one of three groups of 30 each. the ketamine group (groupk) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group m) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group p) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . time to first requirement of analgesic supplement, sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia \[saturation of peripheral oxygen (spo2)\ 4) if time of administration of diclofenac na less than 8h,pethidine 25 mg iv was given.

the patients were randomly allocated to one of three groups of 30 each. the ketamine group (groupk) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group m) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group p) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .

Eligibility criteria:
inclusion criteria: * patients with american society of anesthesiologists(asa) physical status i and ii, undergoing elective cesarean section exclusion criteria: * significant coexisting disease such as hepato-renal and cardiovascular disease * any contraindication to regional anesthesia such as local infection or bleeding disorders * allergy to ketamine or midazolam * long-term opioid use or a history of chronic pain.

Keywords: midazolam ketamine intrathecal pain
drug to prevent pneumonia in the tube fed

Conditions: Pneumonia; Neurological Dysphagia

Summary: background: older people with neurological dysphagia are at risk of recurrent aspiration pneumonia. angiotensin converting enzyme inhibitor (acei) has been shown to improve swallowing and cough reflexes which may protect dysphagic patients from aspiration pneumonia. hypotheses: acei reduces the risk of pneumonia in older patients who are nasogastric tube fed because of dysphagia from cerebrovascular diseases. design: randomized placebo controlled trial method: 302 older patients who have been tube fed for more than two weeks because of dysphagia secondary to cerebrovascular diseases are randomized to take half of lisinopril 5 mg or placebo tablet once daily for 26 weeks. the subjects will be recruited from medical wards in prince of wales and shatin hospitals, and from outpatients of geriatric or speech therapy clinics, who have had hospital stay in previous three months. the subjects are followed up at week 12 and 26. the primary outcome is the incidence rate of pneumonia as determined by pneumonic change on x ray and clinical criteria. the secondary outcomes are mortality rate, total episodes of pneumonia over 26 weeks, and swallowing ability defined by the royal brisbane hospital outcome measure at week 12. cost effectiveness analysis of public health care and personal health care costs will be performed. intention to treat and log rank will be used to analyzed the group differences in outcomes. 60 subjects (30 in each trial group) recruited from medical inpatients at prince of wales hospital will undergo swallowing videofluoscopy at baseline and week 12 follow-up.


Eligibility criteria:
inclusion criteria: * tube fed for more than four weeks for reason of neurological dysphagia as recommended by a trained speech therapist; * clinical diagnosis of cerebrovascular diseases, confirmed by ct head scan. the reason for restricting the subjects to those with cerebrovascular disease is that previous studies which showed beneficial effects of acei on dysphagia were mostly based on stroke patients. exclusion criteria: * life expectancy less than six months; * live outside shatin area; * systolic blood pressure less than 100 mm hg; * known intolerance of acei; * existing use of acei or angiotensin receptor blockers; * symptomatic chronic lung disease or cardiac failure; * frequent withdrawal of enteral tube by patients; * serum creatinine \>100 µmol/l; * serum potassium \> 5.1 mmol/l.

Keywords: rate of pneumonia mortality rate
individualized fortification of breast milk for preterm infants - a pilot study

Conditions: Postnatal Growth Disorder

Summary: to analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.


Eligibility criteria:
inclusion criteria: * birth weight ≤ 1500g and gestational age \< 32weeks * tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h exclusion criteria: * infants fed more than 25% of mean caloric intake for a consecutive week with formula milk * gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities * babies with enterostoma or short gut syndrome * fluid restriction below * renal disease * sepsis * necrotizing enterocolitis * hepatic dysfunction

Keywords: postnatal development breast milk fortification composition of breast milk
prednisone and acupuncture for the treatment of facial neuritis: a multiple center, cer in china

Conditions: Bell's Palsy

Summary: the aim of this study is to compare the effects of prednisolone and staging acupuncture in the recovery of the affected facial nerve, and to verify that whether in combination with staging acupuncture is more effective than prednisolone alone for bell's palsy in a large number of patients.

patients will be recruited between sep, 2010, and dec, 2014. baseline assessments before the start of treatment include neurological examination, grading of facial function, measurement of ipsilateral pain, documentation of concurrent medication. these patients are assigned to receive one of the following treatment groups, i.e. 1)the hormone group: oral hormone drugs, do not accept acupuncture treatment; 2)acupuncture group: using acupuncture therapy, do not accept oral hormone therapy; 3)hormone-acupuncture combined treatment group: receive oral hormone and acupuncture therapy at the same time; 4)other treatment group: other treatment in addition to the above 3 groups of treatment abroad. the secondary factor grouping (subgroup): according to the different time of treatment after the onset of disease, the acupuncture group and the hormone- acupuncture combined treatment group can be divided into type ⅰ subgroup (patients receive acupuncture within 10 days of the onset of disease) and type ii subgroups (patients receive acupuncture after 10 days of the onset of disease). the primary outcome is the time to complete recovery of facial function, assessed by sunnybrook system and house-brackmann scale. the secondary outcomes include the incidence of ipsilateral pain in the early stage of palsy (and the duration of this pain), the proportion of patients with severe pain, the occurrence of synkinesis, facial spasm or contracture, and the severity of residual facial symptoms during the study period.

Eligibility criteria:
inclusion criteria: * involvement of unilateralfacial nerve paralysis only * aged between 18 and 75 years old * period of onset of facial paralysis within 72h exclusion criteria: * pregnancy * breastfeeding * being a woman of child bearing age who is unwilling to use contraceptives during the medication period * other neurological diseases * diabetes * badly controlled hypertension * current or a history of serious heart disease * history of renal or hepatic disease * gastric or duodenal ulcer * history of glaucoma * acute otitis or history of ipsilateral chronic otitis * history of tuberculosis, history of immunodeficiency syndromes * recent head injury, psychiatric disease, or any other condition that is at risk of being inﬂuenced by the study medication or that might have affected completion of the study.

Keywords: bell's palsy prednisolone acupuncture
meteor think niv pilot

Conditions: Acute Respiratory Failure

Summary: this study will pilot test three strategies designed to speed implementation of preventive post-extubation noninvasive ventilation (niv): one control strategy (traditional online continuing medical education) and two novel strategies (interprofessional education and just-in-time education).

during a one-month intervention period, the investigators will pilot test the educational strategies in three participating upmc icus. prior to receiving education, participants will be invited to complete a short online survey. participants in the control group will be invited to complete a 30-minute online continuing education module, which will conclude with a survey. participants in the interprofessional education group will be invited to attend a 90-minute, in-person, interprofessional education session that will occur in or near the participating icu. a trained advance practice provider will provide participants in the just-in-time education group with 5-10 minutes of education in the icu when the icu team is rounding on a patient who is identified to be high risk for extubation failure. the just-in-time education may occur more than once per day, depending on the number of high-risk patients identified. all educational strategies will include content on the benefits of preventive post-extubation niv, the indications and contraindications for preventive post-extubation niv, and the value of working together as an interprofessional icu team when implementing preventive post-extubation niv. each educational intervention will include a survey designed to determine the feasibility, acceptability, and preliminary impact of the educational strategies. the investigators will also directly observe instances of interprofessional and just-in-time education and conduct in-person interviews to assess these factors in a qualitative manner. lastly, during the intervention period and the 6 months before and after the intervention period, the investigators will collect data from the electronic health record and analyze changes in percent of high-risk patients who receive preventive post-extubation niv, reintubation rate, duration of mechanical ventilation, ventilator-associated pneumonia, and in-hospital mortality.

Eligibility criteria:
two study populations will be included. learners (population 1) will include: * frontline care providers, including physicians, advanced practice providers, nurses, and respiratory therapists * working in a participating icu. frontline care providers will be excluded if they: * have not worked in their current upmc icu for more than one month prior to the current study * have not directly cared for a mechanically ventilated patient in a upmc icu during the three months preceding the current study. patients (population 2) will include: * mechanically ventilated patients * treated in the participating icus * surviving to extubation

Keywords: noninvasive ventilation education intensive care unit mechanical ventilation evidence-based practice